Novartis Ag

Carol Ann Morris

Fiona Patricia Carney

John Martin Lally

Yongxing Qiu

Lynn Cook Winterton

Jennifer Dawn Lane

Manal M Gabriel

Nichola Kotov

Courtney Flem Morgan

Marcia Kay Ash

The invention provides methods and kits for monitoring the status of women's health, including HRT monitoring and determination or diagnosis of ovulation, contraception, pregnancy, menopause, polycystic ovarian disease, and female sexual dysfunction. The method comprises the steps of: (a) collecting a tear fluid from a female human; (b) determining the tear concentration of at least one hormone of relevance to female fertility, sexual differentiation or sexual dysfunction in a female human, wherein the tear concentration is diagnostics of the status of women's health.

Method for monitoring fertility by measuring the concentration of hormones in tears

The present invention provides a medical device, preferably a contact lens, which comprises an antimicrobial LbL coating containing one or more antimicrobial pepetides. The antimicrobial coating of the invention can impart to the medical an increased surface hydrophilicity and a relatively high antimicrobial activity coupled with low cytotoxicity. The antimicrobial coating of the invention has a minimal adverse effects on the desirable bulk properties of a contact lens, such as oxygen permeability, ion permeability, and optical properties. An antimicrobial coating of the present invention may find particular use in extended-wear contact lenses. In addition, the invention provides a method for making a medical device, preferably a contact lens, having an antimicrobial LbL coating thereon.

Medical devices having antimicrobial coatings thereon

The present invention provides a method for forming on a medical device, preferably an ophthalmic lens, more preferably a contact lens, a diffusion-controllable coating capable of controlling the out-diffusion or release of guest materials from the medical device. The method of the invention comprises: (1) applying one layer of clay and optionally one or more layers of polyionic materials onto the medical device; or (2) applying alternatively a layer of a first polyionic material and a layer of a second polyionic material having charges opposite of the charges of the first polyionic material onto the medical device and releasing the coated medical device into a releasing medium having a composition capable of imparting a desired permeability to the diffusion-controllable coating on the medical device.

Diffusion-controllable coatings on medical device

The invention provides an in vivo screening assay and an in vitro screening assay for rapid screening of diabetes. A method of the invention includes determining a first glucose concentration in an ocular fluid of a patient; administering orally a load of carbohydrate to the patient; determining a second glucose concentration in an ocular fluid of the patient at a period of time of less than 50 minutes after orally administering of the load of carbohydrate; comparing the second glucose concentration with the first glucose concentration to determine if the patient is likely to be a diabetic. The method of the invention is performed by using a kit of the invention. The kit comprises: (1) a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes; or (2) two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal. The glucose-sensing ophthalmic device comprises a testing agent composition which specifically and reversibly interacts with glucose to form a detectable optical signal which changes in a concentration-dependent manner.

Kits for assays of rapid screening of diabetes

The present invention provides a medical device, preferably a contact lens, which comprises an antimicrobial coating including at least one layer of polyquat of formula (I) or (II). The antimicrobial coating on the medical device of the invention has a high antimicrobial efficacy against microorganisms including Gram-positive and Gram-negative bacterial, a low toxicity, low coefficient of friction, and increased hydrophilicity while maintaining the desired bulk properties such as oxygen permeability and ion permeability of lens material. Such lenses are useful as extended-wear contact lenses. In addition, the invention provides a method for making a medical device, preferably a contact lens, having an antimicrobial coating thereon.

The invention, in one aspect, provides a strip for tear collection. The strip has a first end and an opposite second end and preferably has substantially uniform cross-sections from the first end to the second end. The strip is made of a hydrogel material in substantially dry state. The strip is characterized by having a substantially uniform swelling along the hydrogel strip from the first end to the second end when fully wicked by a tear fluid and by having a correlation between the volume of tear uptake by said strip and the length of the wicked end portion of said strip. A strip of the invention is useful for assay of an analyte of interest in a tear fluid. The invention also provides a method and kits for assaying an analyte of interest (e.g., lactoferrin, glucose, herpes simplex virus, hormones, etc.).

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Duluth, GA, United States of America

Carol Ann Morris